Kornimate/medical-research-clean huggingface dataset:
effect of the "o-ring" technique in reducing cerebrospinal fluid leak in posterior fossa surgery: an explorative study

Conditions: Posterior Fossa Surgery

Summary: posterior fossa surgery represents on of the most demanding procedure in neurosurgery. retrosygmoid (rs), key-hole retrosygmoid (kr) and cerebellar hemispheric (ch) are the most common approaches used to access in this area. despite they are not technically difficult to perform, these approaches can be burdened by postoperative cerebrospinal fluid (csf) leakage, both at short and long-term follow-up, with an high risk of meningitis. many techniques were employed to avoid this risk, but it can still be estimated between 2% and 11% according to literature1-4. spena et al. reported a csf leakage rate of 6.8% in a previous experience5. as a consequence, newer efforts are necessaries to avoid this potentially lethal complication. by this explorative study, we want to retrospectively analyzed our experience with a newer technique of bone closure, called o'ring, in patients subdued to posterior fossa surgery by rs, kr and ch approaches, focusing on postoperative csf leakage (primary objective), wound complications and subcutaneous csf collections (secondary objectives).


Eligibility criteria:
inclusion criteria: * age ≥18 years, * availability of pre- and postoperative radiological and clinical data, * a follow-up period of at least 3 months. exclusion criteria: * lacking of clinical, radiological and surgical data
an evaluation of zinc status biomarkers

Conditions: Inflammation; Oxidative Stress

Summary: the purpose of this study is to determine the effect of a moderate decrease in dietary zinc on dna strand breaks and other cellular zinc biomarkers.

assessing the zinc status of humans has proven to be difficult because of the unique physiological features of zinc homeostasis. animal and human studies show that a small, vulnerable pool of cellular zinc is sensitive to changes in dietary zinc. the protein, metallothionein (mt), is made within cells to stabilize this transient zinc pool and to provide a means to 'park' a small zinc reserve. the overall goal is to develop a new method for measuring mt in cells and to assess other cellular responses to changes in small changes in dietary zinc. culture models of zinc deficiency and excess have been developed and used to test the response of cellular mt levels and mineralization to changes in zinc availability. in phase ii, the changes in the expression of leukocytic zinc transporters and the cellular in vitro uptake of isotopic zinc will be measured. healthy men will be recruited to participate in a 6-week feeding trial to be followed by a 3-week recovery period. the results of this study will determine if potential new cellular zinc biomarkers respond to changes in zinc status when the men are fed an additional 4 mg zinc/d incorporated into a rice-based meal. these findings will provide essential, new information for designing an efficacy trial of biofortified rice and the zinc status of infants and young children.

Eligibility criteria:
inclusion criteria: * willing to limit food and beverage intake to that provided by the study * willing to discontinue consumption of alcoholic beverages during the study * has an operative understanding of english * no plans to move from the area during the study period exclusion criteria: * chronic or acute metabolic disease (i.e., diabetes or asthma) * taking medications for a metabolic disorder * evidence of alcohol abuse or use of illicit drugs

Keywords: zinc dna integrity gene expression diet zinc nutrition requirements
swe liver stiffness as a predictor of progression of chronic liver diseases

Conditions: Liver Fibroses

Summary: this study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (ssi-swe) in patients with liver fibrosis to predict progression of chronic liver disease.


Eligibility criteria:
inclusion criteria: * patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin, * patients who had reached the age of majority in their countries, at baseline, * patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis), * patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded exclusion criteria: * cause of chronic liver disease other than viral, ald or nafld ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) * any systemic, viral hepatitis and hiv co-infection
impact of the microbiome on time to pregnancy and pregnancy outcomes in fertile women attempting to conceive

Conditions: Pregnancy Complications; Contraception; Pregnancy Loss; Fertility; Microbial Colonization; Metabolome

Summary: this study aims to investigate the microbiome of women with previously proven fertility who plan to become pregnant.

the women will be recruited at the time of removal of a copper or hormonal intrauterine device (iud) or removal of a contraceptive implant at the barnmorskemottagningar (midwife clinics) in stockholm's county in sweden. a total of 500 women will be included in the study and will be followed until conception or up to the end of 1 year, whichever comes first. if conception occurs, the woman will be followed throughout pregnancy. participant recruitment will take place over a period of two years.

Eligibility criteria:
inclusion criteria: * women with a previous live birth in the past 5 years and planning a new pregnancy with the same male partner. * 18-40 years of age * swedish personal identity number and a swedish address (to send a sampling self-kit) * sufficient understanding of spoken and written swedish or english to provide informed consent and complete the web-based questionnaire. exclusion criteria: * women who do not have a child yet and plan to cease their contraception.

Keywords: cohort fertility microbiome microbiota
isocyanate dermal exposures in autobody shops

Conditions: Asthma; Lung Diseases

Summary: to characterize the skin route of exposure to the allergen hexamethylene diisocyanate (hdi) in the auto body industry.

background: isocyanates account for the highest number of reported cases of occupational asthma in the united states and developed countries. prevention, however is limited by inadequate knowledge of isocyanate routes of exposure, exposure patterns, mechanisms of sensitization and other causal factors. the survey of painters and repairers of auto bodies by yale (spray), a five-year cross-sectional epidemiologic survey of painters and repairers of autobodies at yale was therefore initiated to address these questions. at the outset of spray, it was not known how frequent skin contact among the painters might be. moreover, there is new and exciting data from animal studies demonstrating that dermal rather than respiratory contact may be crucial to immune sensitization leading to asthma. little is known, so far, about dermal exposure in autobody shops and its modifiers, especially the effectiveness of personal protective equipment (ppe) in preventing workers from skin contamination by isocyanates. design narrative: the study was ancillary to the spray study and was integrated into it. the overall design was a cross-sectional investigation of 20 shops with 120 workers. this would allow a better understanding of the complex basis for asthma risk in these workers, and better recommendations to autobody shops and workers on protective measures for isocyanate dermal exposures. specific aims included: 1) qualitatively and quantitatively assessing surface and skin contamination of hdi; 2) identifying modifiers that affected surface and skin contamination, and specifically evaluating the effectiveness of personal protective equipment in protecting the skin from isocyanate contamination; 3) exploring the relationships of dermal exposure with airborne exposure, biomarkers of systemic absorption and skin sensitization, and asthma-developing risk. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
amo croc study: self-medication and dental pain of pulpal and peri-apical origin. qualitative study

Conditions: Self Medication

Summary: adult patients with dental anxiety or phobia constitute a population for which access to dental care is difficult and this situation is often associated with am low socio-economic status. according to the literature, these patients avoid conventional care, make greater use of emergency services, and self-medicate when experiencing dental pain. moreover, little is known in the literature about the use of self medication in france, although it is known that in the general population does self medicate a lot. the objective of this study is to better understand the self-medication behaviors of patients in order to improve their care. this work aim at characterizing a population of adults in need of treatment for dental pain of pulpal or periapical origin and anxious or phobic adults in need of for dental treatment under general anesthesia. self-medication behaviors will be studied in qualitative research during recorded interviews.


Eligibility criteria:
inclusion criteria: * adults visiting the odontology unit for dental pain due to acute pulpitis or in need of dental treatment under general anesthesia * speaking french * able to give his/her informed consent * affiliated to the health social security system exclusion criteria: * adults under guardianship or curatorship * adults refusing to participate

Keywords: dental anxiety qualitative behaviors self medication
anti-cgrp for inflamation and pain modulation in small fiber neuropathy/fibromyalgia

Conditions: Trigeminal Neuralgia; Glossopharyngeal Neuralgia

Summary: the investigators will treat patients (targeting enrollment of n=20) who suffer from trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy. the primary pain-related objective is reduction of pain and reduced use of rescue and other anti-pain medications. another goal is to monitor and confirm the safety profile established in the migraine population, during previous phase 3 trials.


Eligibility criteria:
inclusion criteria: * age 18-80 years old. * the patient must have an assigned diagnosis of non-neuralgic trigeminal nerve pain g50.1, with all its permutations listed in the icd10 explicitly allowed. co-morbid trigeminal neuralgia g50.0 and g43. ... related headache codes are allowed. as an alternative to trigeminal nerve pain g50.1, glossopharyngeal nerve pain will be another inclusion criterion, with a g52.1 diagnosis and explicit mentioning of pain mediated by or in the innervation territory of the glossopharyngeal nerve. in addition, patients have to be diagnosed with a painful small fiber neuropathy. this diagnosis is based on a skin biopsy or biopsy of an innervated surface epithelium with nerve fiber density count. the required icd10 diagnostic codes are g63.3, g60.8, g62.8. co-morbidity with a fibromyalgia-related disorder will be allowed, typically summarized under a diagnosis code of m79.7. exclusion criteria: * patients that have a history of allergy or allergy-like incompatibility with a biologic that contains a human or humanized monoclonal antibody will be excluded. * female patients of child-bearing age who are or want to become pregnant will be excluded. in case such a patient intends to participate, then she has to commit to a pregnancy prevention regimen that is based on hormonal contraceptive or intra-uterine device.
a study of tirzepatide (ly3298176) compared to dulaglutide in participants with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the reason for this study is to see if the study drug tirzepatide (ly3298176) is effective and safe compared to dulaglutide in participants with type 2 diabetes in japan.


Eligibility criteria:
inclusion criteria: participant must: * have been diagnosed with type 2 diabetes mellitus based on the world health organization classification before the screening visit. * have hba1c meeting the following criteria, as determined by the central laboratory at screening and baseline: * for participants who are oral antihyperglycemic medication (oam)-naïve at screening, ≥7.0% to ≤10.0% at both screening and baseline. * for participants who have been taking oam monotherapy at screening, ≥6.5% to ≤9.0% at screening, and ≥7.0% to ≤10.0% at baseline. * have body mass index (bmi) of ≥23 kilograms per meter squared at screening. * be of stable weight (±5%) during 3 months preceding screening; and agree to not initiate an intensive diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment. exclusion criteria: participant must not: * have type 1 diabetes mellitus. * have had chronic or acute pancreatitis any time prior to study entry. * have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring immediate or urgent treatment. * have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. * have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (alt) enzyme level \>3.0 times the upper limit of normal (uln) for the reference range, as determined by the central laboratory. participants with nonalcoholic fatty liver disease (nafld) are eligible for participation in this trial only if there alt level is ≤3.0 the uln for the reference range. * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. * have been taking weight loss drugs, including over-the-counter medications during the last 3 months.
right ventricular function in patients taking carfilzomib

Conditions: Pulmonary Hypertension

Summary: patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. this is well documented in the literature. however, there are no studies looking at right ventricular function in these patients, both before and during treatment.

patients treated for multiple myeloma in the second line with carfilzomib may develop pulmonary hypertension. this is well documented in the literature. however, there are no studies looking at right ventricular function in these patients, both before and during treatment. patients had a cardiac ultrasound scan prior to the introduction of carfilzomib and an ultrasound scan following the introduction of carfilzomib. we will look at the evolution of right ventricular function parameters in these patients.

Eligibility criteria:
inclusion criteria: * patients treated for multiple myeloma with carfilzomib * patients with echocardiogram before and under treatment. exclusion criteria: * /
protein requirements in adults with phenylketonuria (pku)

Conditions: Phenylketonuria

Summary: phenylketonuria (pku) is an inherited inborn error of phenylalanine (phe) metabolism caused by decreased activity of phenylalanine hydroxylase (pah) enzyme. therefore, phe accumulates in plasma leading to mental problems. treatment is a phenylalanine-restricted diet with sufficient protein. however, the optimum protein requirements are still unknown and compliance with diet is not satisfactory in pku adults. a previously established technique called indicator amino acid oxidation (iaao) will be used to determine protein requirements from amino acid based formula vs. glycomacropeptide (gmp) in adults with pku (≥ 19y). this study will help treat adults with enough protein ensuring maintenance of health.


Eligibility criteria:
inclusion criteria: -adults more than 19 years of age who are diagnosed with pku and clinically stable with no acute illness exclusion criteria: * adults with pku under age 19 year * adults diagnosed with pku but are currently ill with a fever or cold

Keywords: phenylketonuria pku phenylalanine metabolism protein requirements indicator amino acid oxidation stable isotopes gmp glycomacropeptide
fetoscopic selective laser photocoagulation in twin-twin transfusion syndrome

Conditions: Twin to Twin Transfusion Syndrome

Summary: this is a study to compare two treatments (amnioreduction vs. selective fetoscopic laser photocoagulation \[sflp\]) in patients with severe twin to twin transfusion syndrome.

we hypothesize that treatment of the underlying chorioangiopagus by selective fetoscopic laser photocoagulation will not only improve the survival of twins but will reduce the incidence of neurologic, cardiac, and developmental sequelae of twin-twin transfusion syndrome (ttts). we propose to test this hypothesis by a prospective randomized multicenter trial to compare serial amnioreduction with selective fetoscopic laser photocoagulation in cases of severe (stage ii-iv) twin-twin transfusion syndrome (ttts). primary outcomes: survival of donor twin at 30 days after birth and no treatment failure; survival of recipient twin at 30 days after birth and no treatment failure; secondary outcomes: survival times of each twin in utero or after birth (which may be censored at 30 days after birth); gestational age at delivery; placental insufficiency; cardiac outcome: echocardiographic evidence of cardiac compromise; neurologic outcome: evidence of brain injury preceding birth by mri; postnatal comorbidity

Eligibility criteria:
inclusion criteria: * both twins are alive * ttts diagnosed prior to 22 weeks gestation * monochorionic diamniotic gestation * like sex twins * single placental mass * thin intertwin membrane * oligohydramnios in donor twin (deepest vertical pocket of ≤ 2 cm) * polyhydramnios with deepest vertical pocket of \> 8 cm with or without doppler or echocardiographic changes in the recipient twin (deepest vertical pocket of \> 6 cm if previous amnioreduction) * decompressed bladder in donor not seen to fill during the ultrasound examination (stage ii, iii, or iv), unless doppler velocimetry changes (absent end-diastolic umbilical artery flow, abnormal ductus venosus waveform), and/or echocardiographic changes (valvular insufficiency, ventricular hypertrophy) are already present * no associated structural abnormalities * no sonographic evidence of cns injury at time of entry * no preterm labor * no maternal medical contraindication to anesthesia or surgery exclusion criteria: * failure to meet all inclusion criteria * ttts presenting after 22 weeks gestation * randomization after 24 weeks gestation * cervical length \< 2.0 cm post initial * presence of cervical cerclage * uterine anomaly * refusal to accept randomization * unable to pursue prenatal care at an approved center coordinated by one of the participating institutions * unable to pursue postnatal evaluation at a nichd neonatal research network institution

Keywords: twin to twin transfusion syndrome fetoscopic selective laser photocoagulation amnioreduction
exercise activity-based bolus decisions in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in type 1 diabetes.

subjects with type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. the aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (pa) into bolus decisions. it is expected to decrease risk of hypoglycemia related to previous pa and provide better glucose control. the idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.

Eligibility criteria:
inclusion criteria: 1. type 1 diabetes for at least one year 2. using an insulin pump for at least 6 months 3. age 18-65 4. uses insulin parameters such as carbohydrate ratio and correction factors consistently on the insulin pump in order to dose insulin for meals or corrections 5. access to internet and willing to upload data during the study 6. willingness to maintain consistent activity regimen for 28 day collection period 7. females, not currently known to be pregnant. if female and sexually active, must agree to use a form of contraception to prevent pregnancy while participating in the study. a negative urine/blood pregnancy test will be required for all women of child bearing potential. subjects who become pregnant will be discontinued from the study. 8. demonstration of proper mental status and cognition for the study. 9. an understanding of and willingness to follow the protocol and sign the informed consent. exclusion criteria: 1. diabetic ketoacidosis (dka) in the 6 months prior to enrollment. 2. severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment. 3. pregnancy and intent to become pregnant during trial. 4. use of acetaminophen is not allowed when cgm is in use 5. use of non-insulin medications intended to lower glucose (e.g. glucagon-like peptide \[glp\]-1 agonists, metformin) 6. currently uses a clearly defined method for insulin bolusing to compensate for significant activity (e.g. marathon runner who uses temporary basal rates routinely and has separate basal profiles to account for exercise) 7. inability to be physically active for more than 30 minutes per day. 8. current enrollment in another intervention clinical trial.

Keywords: type 1 diabetes mellitus insulin pump continuous glucose monitor (cgm) exercise activity on board decision support system
a study of ak106-001616 in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: to investigate the efficacy and safety of ak106-001616 in patients with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * diagnosis of ra (class i to iii) * stable dose of methotrexate (at least 12 weeks) exclusion criteria: * pregnant or breastfeeding * abnormal screening laboratory test values considered to be clinically significant